Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

This study was conducted at 575 sites in 40 countries between August 22, 2003 and December 19, 2011. Three sites were closed and data from these sites were not analyzed following site audits and in compliance with rulings from national health authorities.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

The purpose of the factorial design was to efficiently answer two independent scientifically worthwhile questions regarding insulin glargine and omega-3 fatty acids within the context of a single clinical trial. Sample size was determined based on the insulin glargine study objective. Results reported below are those of the insulin glargine study.

Reporting Groups

Description

Insulin Glargine

Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids

Standard Care

Standard care with or without omega-3 polyunsaturated fatty acids

Participant Flow: Overall Study

Insulin Glargine

Standard Care

STARTED

6264 [1]

6273 [1]

Safety Population (Treated)

6231 [2]

6273 [3]

COMPLETED

5052 [4]

6273 [5]

NOT COMPLETED

1212

0

Adverse Event

105

0

Withdrawal by Subject

1090

0

Other

17

0

[1]

randomized participants = intent-to-treat (ITT) population

[2]

randomized patients who received at least one dose of insulin glargine

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Insulin Glargine

Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids

Standard Care

Standard care with or without omega-3 polyunsaturated fatty acids

Total

Total of all reporting groups

Baseline Measures

Insulin Glargine

Standard Care

Total

Overall Participants Analyzed [Units: Participants]

6264

6273

12537

Age [Units: Years]Mean (Standard Deviation)

63.5 (7.8)

63.5 (7.9)

63.5 (7.8)

Gender, Customized [Units: Participants]

Male

4181

3969

8150

Female

2082

2304

4386

Missing value

1

0

1

Baseline Weight [1] [Units: Kg]Mean (Standard Deviation)

83.33 (16.77)

83.13 (17.28)

83.23 (17.03)

[1]

Due to missing values, N=6256 for insulin glargine and N=6271 for standard care.

Baseline Body Mass Index [1] [Units: Kg/m²]Mean (Standard Deviation)

29.77 (5.17)

29.88 (5.33)

29.82 (5.25)

[1]

Due to missing values, N=6251 for insulin glargine and N=6270 for standard care.

Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG [ Time Frame: from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years) ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
"The Steering Committee will be responsible for preparing summaries of the study results for publication in the medical literature, and will have the right to submit such summaries for publication after a review by the sponsor. In such cases comments from the sponsor to the Steering Committee are to be provided within 15 working days. All comments will be carefully considered by the Steering Committee who nevertheless have the final decision on the content of the manuscript."